The invention is concerned with means for the at least partial production or reproduction of biological parts, especially of organs for living-beings, which contains, among other things, an active ingredient complex with the following components, which are different from one another and are specifically suited to each biological part to be produced, in the form of at least one structural component on the basis of extracellular material specifically suited to the cells of each biological part to be produced, at least one recruiting component, at least one adhesion component, and at least one growth and/or maturation component.
In the prior art, an active ingredient complex for the production of biological parts, especially of organs for living-beings, with the mentioned components is already known. In this known active ingredient complex, the structural component can consist, for example, of various types of collagen, elastin, or proteoglycans. As recruiting component for this active ingredient complex, especially chemotactic substances should be mentioned, for example, peptides such as N-F-Met-Leu-Phe- and/or metabolites of arachidonic acid such as leukotrienes.
Proteins of the type of fibronectin or laminin, but also cell-adhesion molecules such as L-CAM, N-CAM, and matrix-adhesion molecules such as cytotactin, tenascin, collagen types IV, V, and VII, synthetic peptides, and trans-membrane compound proteins such as integrin can be used as adhesion components. The examples for adhesion components that were mentioned first—fibronectin and laminin—are to be classified in the area of matrix-adhesion molecules for the purposes of the active ingredient complex explained here. As additional components, the active ingredient complex mentioned shows (or comprises) at least one growth and/or maturation component, preferably in the form of one or several cytokines. Examples of such cytokines are the colony-stimulating factors for the production of blood, the fibroblast growth factor for the production of connective tissue, the epidermal growth factor for the production of skin, the cartilage inducing factor for the production of cartilage, the lymphocyte-activating factor as well as spleen peptides for the production of the spleen or the lymph nodes, the T-cell growth factor as well as thymus peptides for the production of thymus, the bone growth factor as well as the transforming growth factor for the production of bones, and the angiogenesis factor for the production of blood vessels. Moreover, the following cytokines are used: interleukins, insulinlike growth factors, tumor-necrosis factor, prostaglandins, leukotrienes, transforming growth factors, growth factor derived from platelets, interferons as well as growth factor derived from endothelial cells.
The details of this active ingredient complex can be taken from German patent DE 39 36 568.9, whose disclosure is expressly included herewith.
In order to be able to be used for the production or reproduction of biological parts, the active ingredient complex must be available in highly purified form. The production of this active ingredient complex is thus both time-consuming and expensive. For example, when using this active ingredient complex to fill up bone defects with bones, one needs an amount of the active ingredient complex that fills up the entire bone defect. The fact that the active ingredient complex is highly effective, but nonetheless very expensive, is therefore a disadvantage.
If larger bone defects are to be filled, the inserted implant that consists of the active ingredient complex must also have a sufficient mechanical stability of its own so that it is not compressed by the surrounding soft tissue. The active ingredient complex after its production has a cotton-like consistency. For this reason, the application mentioned either must be compressed—which leads to a higher mechanical stability, but also to excessive consumption of material—or a sufficiently stable carrier must be employed together with the active ingredient complex. The combination of a carrier with the active ingredient complex is, however, hardly free of problems. According to the existing knowledge on the active ingredient complex and its complex mode of action, one should be concerned at least about a hindrance of the formation or reproduction of each of the biological parts to be treated, e.g., the regeneration of bone. The risk of a reaction toxic to the tissue was also suspected.
Moreover, applications of the active ingredient complex in disorders or defects have not been possible if the implants consisting of the active ingredient complex are subject to such high mechanical stresses that even the mechanical stability of a compressed material does not suffice.